Actively Recruiting
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research
Led by Zhejiang University · Updated on 2026-03-13
36
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
L
Leman Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus
CONDITIONS
Official Title
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent approved by the Ethics Committee before screening
- Age over 18 years, any gender
- Diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics criteria
- SLE history of at least 6 months and active disease for at least 2 months despite stable standard treatment
- Stable corticosteroid regimen with prednisone (or equivalent) 7.5 to 60 mg/day or corticosteroids combined with immunosuppressants for at least 8 weeks prior to screening
- Positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies at screening
- SELENA-SLEDAI score of 8 or higher during screening, or 6 or higher for clinical symptoms if low complement and/or anti-DS-DNA antibodies present
- Use of effective contraception for women of childbearing age and all males for at least 12 months post-infusion
- Positive CD19 expression by flow cytometry
- Adequate organ function including blood counts, liver and kidney function tests meeting specified thresholds
- Pulmonary function with oxygen saturation over 91% and dyspnea grade 1 or less
- Hemodynamic stability with left ventricular ejection fraction 45% or higher
You will not qualify if you...
- Severe lupus nephritis with proteinuria over 6 g/24h or serum creatinine over 2.5 mg/dL or 221 bcmol/L
- Recent treatment with prohibited drugs for active nephritis, hemodialysis, or high-dose prednisone ( mg/d or equivalent) within 8 weeks prior to screening
- Other active lupus crises such as severe central nervous system lupus, severe blood disorders, severe heart or lung damage, severe hepatitis, or vasculitis prior to screening
- Significant central nervous system diseases not caused by lupus including stroke, epilepsy, severe brain injury, dementia, or psychosis
- Presence of other autoimmune diseases requiring systemic treatment
- History of major organ or hematopoietic stem cell/bone marrow transplantation
- IgA deficiency with serum IgA level below 10 mg/dL at screening
- Any other condition considered by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
M
Mingming Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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